Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

ESS505 Pre-hysterectomy Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01664052
Recruitment Status : Completed
First Posted : August 14, 2012
Results First Posted : May 19, 2016
Last Update Posted : August 4, 2016
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Condition Contraception
Interventions Device: ESS505 (Essure, BAY1454033)
Device: ESS305 (Essure, BAY1454032)
Device: ESS505-A (Essure, BAY1454033)
Enrollment 66
Recruitment Details 66 participants were enrolled in two centers.
Pre-assignment Details  
Arm/Group Title ESS505-A (Essure, BAY1454033) ESS 305/ESS 505 (Essure, BAY1454032/Essure, BAY1454033)
Hide Arm/Group Description Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
Period Title: Phase 1
Started 31 [1] 0
Insert Placed in at Least One Tube 25 0
HSG 1 Hour Post Placement 24 0
Repeat HSG and Hysterectomy at 30 Days 9 0
Repeat HSG and Hysterectomy at 60 Days 8 0
Repeat HSG and Hysterectomy at 90 Days 7 0
Completed 24 0
Not Completed 7 0
Reason Not Completed
No device placement             6             0
No HSG 1 hr post placement             1             0
[1]
Screening and enrollment
Period Title: Phase 2
Started 0 [1] 35
Insert Placed 0 31
HSG 1 Hour Post Placement 0 31
Repeat HSG and Hysterectomy at 30 Days 0 10
Repeat HSG and Hysterectomy at 60 Days 0 10
Repeat HSG and Hysterectomy at 90 Days 0 10
Completed 0 31
Not Completed 0 4
Reason Not Completed
No device placement             0             4
[1]
Screened and enrolled
Arm/Group Title ESS505-A ESS305/ESS505 Total
Hide Arm/Group Description Bilateral placement of Essure 505A (BAY1454033) insert (with minimal PET fiber). Unilateral placement of Essure 505 (BAY1454033) insert (PET-inclusive) and Contralateral placement of the current commercial Essure device Essure 305 (BAY1454032) Total of all reporting groups
Overall Number of Baseline Participants 31 35 66
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 31 participants 35 participants 66 participants
42
(31 to 49)
40
(28 to 52)
41
(28 to 52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 35 participants 66 participants
Female
31
 100.0%
35
 100.0%
66
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Occluded Fallopian Tubes 60 Minutes After Placement of the Insert as Measured by an HSG Evaluation
Hide Description Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion.
Time Frame 60 minutes after insert placement
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ESS505-A (Essure, BAY1454033) ESS305 (Essure, BAY1454032) ESS505 (Essure, BAY1454033)
Hide Arm/Group Description:
Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.
Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
Overall Number of Participants Analyzed 24 31 31
Overall Number of Units Analyzed
Type of Units Analyzed: Fallopian tubes
39 31 29
Measure Type: Number
Unit of Measure: Occluded fallopian tubes
ESS505-A 36 NA [1]  NA [1] 
ESS305 NA [2]  3 NA [2] 
ESS505 NA [3]  NA [3]  28
[1]
ESS505-A not investigated in this group
[2]
ESS305 not investigated in this group
[3]
ESS505 not investigated in this group
2.Primary Outcome
Title Number of Occluded Fallopian Tubes 30 Days Following Placement as Measured by an HSG Evaluation
Hide Description Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.
Time Frame 30 days after insert placement
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ESS505-A (Essure, BAY1454033) ESS305 (Essure, BAY1454032) ESS505 (Essure, BAY1454033)
Hide Arm/Group Description:
Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.
Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
Overall Number of Participants Analyzed 9 10 10
Overall Number of Units Analyzed
Type of Units Analyzed: Fallopian tubes
15 10 10
Measure Type: Number
Unit of Measure: Occluded fallopian tubes
ESS505-A 15 NA [1]  NA [1] 
ESS305 NA [2]  10 NA [2] 
ESS505 NA [3]  NA [3]  10
[1]
ESS505-A not investigated in this group
[2]
ESS305 not investigated in this group
[3]
ESS505 not investigated in this group
3.Primary Outcome
Title Number of Occluded Fallopian Tubes 60 Days Following Placement as Measured by an HSG Evaluation
Hide Description Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.
Time Frame 60 days after insert placement
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ESS505-A (Essure, BAY1454033) ESS305 (Essure, BAY1454032) ESS505 (Essure, BAY1454033)
Hide Arm/Group Description:
Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.
Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
Overall Number of Participants Analyzed 8 10 10
Overall Number of Units Analyzed
Type of Units Analyzed: Fallopian tubes
13 10 9
Measure Type: Number
Unit of Measure: Occluded fallopian tubes
ESS505-A 12 NA [1]  NA [1] 
ESS305 NA [2]  10 NA [2] 
ESS505 NA [3]  NA [3]  9
[1]
ESS505-A not investigated in this group
[2]
ESS305 not investigated in this group
[3]
ESS505 not investigated in this group
4.Primary Outcome
Title Number of Occluded Fallopian Tubes 90 Days Following Placement as Measured by an HSG Evaluation
Hide Description Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.
Time Frame 90 days after insert placement
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ESS505-A (Essure, BAY1454033) ESS305 (Essure, BAY1454032) ESS505 (Essure, BAY1454033)
Hide Arm/Group Description:
Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.
Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
Overall Number of Participants Analyzed 7 10 10
Overall Number of Units Analyzed
Type of Units Analyzed: Fallopian tubes
11 10 10
Measure Type: Number
Unit of Measure: Occluded fallopian tubes
ESS505-A 10 NA [1]  NA [1] 
ESS305 NA [2]  10 NA [2] 
ESS505 NA [3]  NA [3]  10
[1]
ESS505-A not investigated in this group
[2]
ESS305 not investigated in this group
[3]
ESS505 not investigated in this group
Time Frame Adverse event data were collected after signing the informed consent up to 90 days after insert placement.
Adverse Event Reporting Description The reported adverse events cannot be localized to either intervention for women in receipt of ESS305/ESS505, therefore the observed adverse events were reported in a single arm.
 
Arm/Group Title ESS505-A (Essure, BAY1454033) ESS 305/ESS 505 (Essure, BAY1454032/Essure, BAY1454033)
Hide Arm/Group Description Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
All-Cause Mortality
ESS505-A (Essure, BAY1454033) ESS 305/ESS 505 (Essure, BAY1454032/Essure, BAY1454033)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ESS505-A (Essure, BAY1454033) ESS 305/ESS 505 (Essure, BAY1454032/Essure, BAY1454033)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/31 (0.00%)      0/35 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ESS505-A (Essure, BAY1454033) ESS 305/ESS 505 (Essure, BAY1454032/Essure, BAY1454033)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/31 (6.45%)      5/35 (14.29%)    
Blood and lymphatic system disorders     
Anemia * 1  1/31 (3.23%)  1 0/35 (0.00%)  0
Cardiac disorders     
Bradycardia * 1  1/31 (3.23%)  1 0/35 (0.00%)  0
Gastrointestinal disorders     
Abdominal discomfort * 1  0/31 (0.00%)  0 2/35 (5.71%)  2
General disorders     
Sensation of pressure * 1  0/31 (0.00%)  0 1/35 (2.86%)  1
Reproductive system and breast disorders     
Vaginal laceration * 1  0/31 (0.00%)  0 1/35 (2.86%)  1
Vascular disorders     
Hot flush * 1  0/31 (0.00%)  0 1/35 (2.86%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (15.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A PI may be requested to delay results communications up to 18 months following study conclusion or until a summary of all study results initiated by Sponsor (first publication) has been published. Following first publication embargo, sponsor may review results communications for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor may request a postponement of results communications not to exceed 180 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head
Organization: BAYER
EMail: clinical-trials-contact@bayerhealthcare.com
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01664052     History of Changes
Other Study ID Numbers: 17035
ESS505-002 ( Other Identifier: Company internal )
First Submitted: August 7, 2012
First Posted: August 14, 2012
Results First Submitted: February 3, 2016
Results First Posted: May 19, 2016
Last Update Posted: August 4, 2016